Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT00954005
Status:
TERMINATED
Last Update Posted:
2015-08-19
First Post:
2009-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'Predefined termination criterion of \\> 10 patients without CR or PR was matched.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2009-08-04', 'studyFirstSubmitQcDate': '2009-08-04', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Remission Rate', 'timeFrame': 'end of therapy'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '5 years'}, {'measure': 'Median Overall Survival', 'timeFrame': '5 years'}, {'measure': 'Toxicity', 'timeFrame': '5 years', 'description': 'Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['relapsed indolent lymphoma', 'gemcitabine', 'oxaliplatin', 'rituximab'], 'conditions': ['Indolent Lymphoma']}, 'referencesModule': {'references': [{'pmid': '38459156', 'type': 'DERIVED', 'citation': 'Scheubeck G, Hoffmann M, Jurinovic V, Fischer L, Unterhalt M, Schmidt C, Bock HP, Duhrsen U, Kaesberger J, Kremers S, Lindemann HW, Mantovani L, Hiddemann W, Hoster E, Dreyling M; German Lymphoma Alliance (GLA). Rituximab, gemcitabine and oxaliplatin in relapsed or refractory indolent and mantle cell lymphoma: results of a multicenter phase I/II-study of the German Low Grade Lymphoma Study Group. Ann Hematol. 2024 Jul;103(7):2373-2380. doi: 10.1007/s00277-024-05689-w. Epub 2024 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for therapy in patients with relapsed/refractory patients\n* Histological proven diagnosis of an indolent B-cell lymphoma according to the World Health Organization (WHO) classification belonging to one of the following entities:\n\n * follicular lymphoma\n * mantle cell lymphoma\n * lymphoplasmacytic lymphoma\n * nodal or splenic marginal zone lymphoma\n * measurable disease\n * lymphoma specific therapy in the last four weeks\n * WHO performance grade 0, 1 or 2\n\nExclusion Criteria\n\n* Patients suitable for high dose therapy\n* Transformation in high grade lymphoma\n* Leukocytes \\< 1,5/nl or platelets \\< 100/nl (except due to lymphoma)'}, 'identificationModule': {'nctId': 'NCT00954005', 'acronym': 'R-GO', 'briefTitle': 'Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'German Low Grade Lymphoma Study Group'}, 'officialTitle': 'Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab, Gemcitabine and Oxaliplatin', 'description': 'Drug: Rituximab on day 0 or 1 of each 28-day cycle Drug: Gemcitabine on day 1 and 15 of each 28-day cycle Drug: Oxaliplatin on day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²) of each 28-day cycle', 'interventionNames': ['Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin']}], 'interventions': [{'name': 'Therapy with Rituximab, Gemcitabine and Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Rituximab = Mabthera, Rituxan', 'Gemcitabine = Gemzar', 'Oxaliplatin = Eloxatin'], 'description': 'Rituximab 375 mg/m² day 0 or 1, Gemcitabine 1.000 mg/m² in 30 Min. day 1 and 15, Oxaliplatin 70 mg/m² in 120 Min. day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²), repetition at day 29 for 4 cycles', 'armGroupLabels': ['Rituximab, Gemcitabine and Oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}], 'overallOfficials': [{'name': 'Martin Hoffmann, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Low Grade Lymphoma Study Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Low Grade Lymphoma Study Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Martin Hoffmann, Klinikum Ludwigshafen', 'investigatorFullName': 'Martin Hoffmann', 'investigatorAffiliation': 'German Low Grade Lymphoma Study Group'}}}}